目的：比较埃克替尼与吉非替尼治疗既往化疗失败的局部晚期或转移性非小细胞肺癌（NSCLC）患者的近期疗效及不良反应情况。方法：通过Medline、Embase、Cochrane图书馆、中国生物医学文献数据库、中国期刊全文数据库、中文生物医学期刊文献数据库和数字化期刊全文数据库等全面检索国内外相关文献，纳入埃克替尼和吉非替尼治疗既往化疗失败的局部晚期或转移性NSCLC的随机对照试验（RCTs），并对文献进行筛选、评价与分析。采用RevMan 4.2软件对入选研究的近期疗效及不良反应进行Meta分析。结果：共纳入符合标准的RCTs 2项，涉及423例病例。系统评价显示，异质性检验结果良好，可用固定效应模型进行分析。埃克替尼组与吉非替尼组比较，4周疾病控制率、半年总生存率、1年总生存率均无明显差异；埃克替尼组的28周疾病控制率优于吉非替尼组（P＝0.01）；埃克替尼组与吉非替尼组的皮疹、腹泻、咯血发生率均无显著差异，但埃克替尼治疗组的总不良反应发生率显著低于吉非替尼（P＜0.00001）。结论：对于既往化疗失败的局部晚期或转移性NSCLC，埃克替尼的疗效与吉非替尼相当，且总的耐受性优于吉非替尼。%OBJECTIVE:To evaluate the short-term efficacy and safety of icotinib versus gefitinib for localized advanced or metastatic non-small-cell lung carcinoma (NSCLC). METHODS:The randomized controlled trials (RCTs) both at home and abroad on icotinib versus gefitinib for treatment of localized advanced or metastatic NSCLC after treatment failure with chemothera-py were retrieved from such databases as Medline,Embase,Cochrane Library,CBM,CNKI,CMCC and Wanfang database. Liter-ature screening,assessment and analysis were carried out. Meta-analysis on the short-term efficacy and safety of the drugs were per-formed using RevMan 4.2. RESULTS:Two RCTs involving 423 patients meeting our inclusion criteria were included. The Me-ta-analysis revealed satisfactory homogeneity test results which can be analyzed using fixed effect model and no significant differenc-es between gefitinib and icotinib in disease control rate of 4 weeks,half year survival rate and 1-year survival rate. However,the icotinib group showed better disease control rate of 28 weeks than did gefitinib group. No significant differences were noted be-tween gefitinib group and icotinib group in the incidences of rash,diarrhea and hemoptysis;however,the total incidence rate of ad-verse drug reactions in icotinib group was statistically lower than in the gefitinib group (P<0.000 01). CONCLUSIONS:For pa-tients with advanced NSCLC,icotinib is similar to gefitinib in efficacy and has better tolerance than gefitinib.
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